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Novartis provides second US university with Bexsero® to help protect students and staff against potentially deadly meningitis B disease

February 24, 2014

- FDA granted special use of Bexsero for nearly 20,000 UCSB students and staff in response to outbreak; the vaccine is licensed in Europe, Australia and Canada

CAMBRIDGE, Mass., Feb. 24, 2014 /PRNewswire/ — Novartis announced today that its meningococcal serogroup B (MenB) vaccine, Bexsero(®) (Meningococcal Group B Vaccine [rDNA, component, adsorbed]), will be used as part of a vaccination program at the University of California Santa Barbara (UCSB) that began today and will end on March 7. In the last three months, the Food and Drug Administration (FDA) has approved the use of Bexsero twice in response to MenB outbreaks at US college campuses(1). More than 5,000 students were vaccinated at Princeton University and 20,000 students will be offered vaccination at UCSB(2).

Bexsero is the only licensed broad coverage vaccine approved in Europe, Canada and Australia to help protect against invasive meningococcal disease caused by serogroup B. It was approved for use in the US under a treatment Investigational New Drug (IND) designation. Under this process, many weeks are required to gain administrative approvals, organize supply and delivery of the vaccine from countries where it is being used, and decide how vaccination programs will be managed at local sites.

Granting a US license for Bexsero for use in all adolescents and young adults would enable immediate response to future outbreaks and allow US families to have access to a vaccine to help protect against MenB.

“Having lost my son to meningitis, I know how dangerous the disease is and how quickly it can strike someone,” said Lynn Bozof, President of the National Meningitis Association. “Because it is impossible to know who will be affected and when, we look forward to the day when there is a licensed MenB vaccine in the US, which could help prevent other families from experiencing the devastation this disease causes.”

“These recent outbreaks remind us how unpredictable the disease can be and demonstrate the need to license Bexsero in the US. This would enable us to quickly respond to future outbreaks, while also having a vaccine available for those who might pre-emptively choose to protect themselves against the disease,” said Andrin Oswald, Division Head, Novartis Vaccines. “We will continue to work with the FDA to pursue a potential license for Bexsero in the US to help fulfill this public health need.”

Novartis has submitted data from Bexsero’s comprehensive clinical program to the FDA, including information from clinical studies with almost 8,000 infant, children, adolescent and adult participants, which supported the licensure of the vaccine in Europe, Australia and Canada(1).

While rare, MenB is a bacterial infection that progresses rapidly and can lead to death or permanent disability within 24 hours of symptom onset(3,4). Because initial symptoms are often unspecific and flu-like, it can be difficult for even a healthcare professional to diagnose the disease in its early stages. About one in 10 of those with the disease will die despite treatment; and of those who do survive, one in five will suffer from devastating, life-long disabilities such as brain damage, hearing loss or limb loss(3).

Adolescents and young adults are at an increased risk of contracting meningococcal disease, which is associated with changes in behavior and lifestyle(5,6,7). These age groups also have an unusually high case fatality rate from meningococcal disease(5,6). Further, adolescents and young adults are more likely to be carriers of the bacteria than other age groups and can transmit the bacteria to family and friends(8).

Outbreaks of invasive meningococcal disease happen without warning and the most effective way to prevent and control this aggressive disease is through the use of vaccines. A study published in Clinical Infectious Diseases in 2006 characterized outbreak-associated and sporadic cases in the US from 1992 through 2002 and identified 69 outbreaks (3-14 outbreaks per year)(9). From a public health standpoint, these outbreaks are disruptive to individuals and their communities, as they can create alarm and require extensive resources to manage, and those affected by the disease can suffer from serious disabilities. Currently, adolescents in the US are recommended to be vaccinated against four other serogroups that can cause bacterial meningitis (A, C, W-135 and Y)(10).

For the vaccination program at UCSB, the Centers for Disease Control and Prevention (CDC) recommends that the following groups receive the vaccine:

    --  All UCSB undergraduates and University Immersion Program students
    --  The small number of faculty, staff and graduate students who have
        certain specific medical conditions or who live in University-owned
        dormitory-style residence halls(11)

Disclaimer

The foregoing release contains forward-looking statements that can be identified by words such as “potentially,” “pursuing,” “would,” “unpredictable,” “can,” “will,” “offered,” “could,” “might,” “pre-emptively,” “continue,” “pursue,” “potential,” “risk,” “more likely,” “recommends,” or similar terms, or by express or implied discussions regarding potential additional marketing approvals for Bexsero, or regarding potential future revenues from Bexsero. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that Bexsero will be submitted or approved for sale in the US or additional markets, or at any particular time. Nor can there be any guaranty that Bexsero will be commercially successful in the future. In particular, management’s expectations regarding these products could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; global trends toward health care cost containment, including ongoing pricing pressures; unexpected manufacturing issues; the company’s ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis

Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2013, the Group achieved net sales of USD 57.9 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 136,000 full-time-equivalent associates and operate in more than 140 countries around the world.

For more information, please visit http://www.novartis.com.

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References

    1. Centers for Disease Control and Prevention. Serogroup B Meningococcal
       Vaccine and Outbreaks: Questions and Answers. Available at:

http://www.cdc.gov/meningococcal/outbreaks/vaccine-serogroupB.html.

       Accessed February 2014.
    2. Centers for Disease Control and Prevention. Princeton University
       Meningococcal Disease Outbreak. December 2013. Available at:
       http://www.cdc.gov/meningococcal/outbreaks/princeton.html. Accessed
       February 2014.
    3. Mayo Foundation for Medical Education and Research. Meningitis. April
       2011. Available at:

http://www.mayoclinic.com/health/meningitis/DS00118/DSECTION=symptoms.

       Accessed February 2014.
    4. World Health Organization. Meningococcal meningitis. Fact sheet #141.
       November 2012. Available at:
       http://www.who.int/mediacentre/factsheets/fs141/en/. Accessed February
       2014.
    5. Cohn, A. et al. Changes in Neisseria meningitides Disease Epidemiology in
       the United States, 1998-2007: Implications for Prevention of
       Meningococcal Disease. Clinical Infectious Diseases. (2013) 50 (2):
       184-191. Available at
       http://cid.oxfordjournals.org/content/50/2/184.full.pdf+html.  Accessed
       February 2014.
    6. Harrison LH, Pass MA, Mendelsohn AB, et al. Invasive Meningococcal
       Disease in Adolescents and Young Adults. JAMA. 2001:286(6): 694-699.
       Available at: http://jama.jamanetwork.com/article.aspx?articleid=194084.
       Accessed February 2014.
    7. Harrison LH. A New Era in Adolescent Immunization. National Foundation of
       Infectious Diseases. Available at:
       http://www.medscape.com/infosite/nfid/article-1.  Accessed February 2014.
    8. National Advisory Committee on Immunization. Update on the Invasive
       Meningococcal Disease and Meningococcal Vaccine Conjugate
       Recommendations. Canada Communicable Disease Report. April 2009, Vol. 36.
       Available at:

http://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/09pdf/acs-dcc-3.pdf.

       Accessed February 2014.
    9. Brooks R, Woods CW, Benjamin DK, Jr., Rosenstein NE. Increased
       case-fatality rate associated with outbreaks of Neisseria meningitidis
       infection, compared with sporadic meningococcal disease, in the United
       States, 1994-2002. Clinical Infectious Disease. (2006) 43 (1): 49-54.
       Available at: http://www.ncbi.nlm.nih.gov/pubmed/16758417. Accessed
       February 2014.
    10. Centers for Disease Control and Prevention. University of California,
        Santa Barbara Meningococcal Disease Outbreak. January 2013. Available
        at: http://www.cdc.gov/meningococcal/outbreaks/ucsb.html. Accessed
        February 2014.
    11. Centers for Disease Control and Prevention. Prevention and Control of
        Meningococcal Disease: Recommendations of the Advisory Committee on
        Immunization Practices (ACIP). March 2013. Available at:
        http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6202a1.htm. Accessed February
        2014.

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